Table 2.
Efficacy
| Etirinotecan pegol (n = 36) | TPC (n = 31) | P-value | |
|---|---|---|---|
| BMH subgroup | |||
| Objective response rate (systemic) | 5 (15.6%) | 1 (3.7%) | 0.20 |
| Evaluable populationa | n = 32 | n = 27 | |
| 95% CI | 5.3–32.8 | 0.1–19.0 | |
| Complete response | 0 | 0 | |
| Partial response | 5 (15.6%) | 1 (3.7%) | |
| Stable disease | 9 (28.1%) | 9 (33.3%) | |
| Progressive disease | 14 (43.8%) | 9 (33.3%) | |
| Not evaluable | 4 (12.5%) | 8 (29.6%) | |
| Overall survival (months) | |||
| Median | 10.0 | 4.8 | <0.01 |
| 95% CI | 7.8–15.7 | 3.7–7.3 | |
| 6-month OS rate | 72.2% | 45.2% | |
| 12-month OS rate | 44.4% | 19.4% | |
| Progression-free survival (months) | |||
| Median | 3.1 | 2.7 | 0.52 |
| 95% CI | 1.8–4.0 | 1.8–3.7 | |
| 3-month PFS rate | 50.1% | 50.0% | |
| 6-month PFS rate | 28.6% | 19.5% | |
| Etirinotecan pegol (n = 19) | TPC (n = 18) | P-value | |
|---|---|---|---|
| Radiologically detectable brain lesions at study entry | |||
| Objective response rate (systemic) | 4 (25%) | 1 (6.3%) | 0.33 |
| Evaluable populationa | n = 16 | n = 16 | |
| 95% CI | 7.3–52.4 | 0.2–30.2 | |
| Complete response | 0 | 0 | |
| Partial response | 4 (25.0%) | 1 (6.3%) | |
| Stable disease | 5 (31.3%) | 6 (37.5%) | |
| Progressive disease | 6 (37.5%) | 4 (25.0%) | |
| Not evaluable | 1 (6.3%) | 5 (31.3%) | |
| Progressive disease in brain lesion | 6 (37.5%) | 6 (37.5%) | |
| Overall survival (months) | |||
| Median | 13.2 | 5.8 | 0.02 |
| 95% CI | 8.6–19.6 | 3.5–8.6 | |
| 6-month survival rate | 89.5% | 50.0% | |
| 12-month survival rate | 57.9% | 22.2% | |
| OS by GPA category—BMH Subgroup | Etirinotecan pegol (n = 36) | TPC (n = 31) | P-value |
|---|---|---|---|
| 0–2 | |||
| n | 13 | 10 | |
| Median, months | 7.8 | 3.8 | <0.01 |
| 2.5–4 | |||
| n | 23 | 21 | |
| Median, months | 13.2 | 6.9 | 0.06 |
| OS by GPA category—radiologically detectable brain lesions at baseline | Etirinotecan pegol (n = 19) | TPC (n = 18) | P-value |
|---|---|---|---|
| 0–2 | |||
| n | 6 | 5 | |
| Median, months | 9.6 | 3.5 | |
| 2.5–4 | |||
| n | 13 | 13 | |
| Median, months | 16.8 | 6.9 | |
aEfficacy evaluable population (measureable systemic disease at baseline required)
BMH history of treated, stable breast cancer brain metastases, CI confidence interval, GPA graded prognostic assessment, OS overall survival, PFS progression-free survival, SD stable disease, TPC treatment of physician’s choice